Handheld Ultrasound Device and Replaceable Tips Therefor

ABSTRACT

Handheld ultrasound devices and replaceable tips for such devices are provided. For example, a handheld ultrasound device comprises a handle and a tip that includes a sensor for transmitting and receiving ultrasound waves. The handle and the tip may be a single, integral, unit or the tip may be separable from the handle. In either embodiment, the handle and tip together are a fully self-contained unit. Also provided are handheld ultrasound sterile assemblies, comprising a handheld ultrasound device and a sheath that fully covers the device to provide a sterile barrier for the device. Further, tips for handheld ultrasound devices are provided. The tips may be a replaceable component of the handheld ultrasound devices. For example, the tips may be configured for one-time use, and the tip rather than the entire handheld ultrasound device may be replaced between procedures such that a new tip is used in a subsequent procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional ApplicationSer. No. 62/681,781, filed on Jun. 7, 2018, which is incorporated hereinin its entirety by reference thereto.

FIELD

The present subject matter relates generally to ultrasound devices. Moreparticularly, the present subject matter relates to handheld ultrasounddevices and replaceable tips for handheld ultrasound devices.

BACKGROUND

Doppler ultrasound may be used in surgical and clinical settings toassess the strength and pattern of blood flowing through vessels.Typically, a transducer probe or sensor translates electrical signalsinto waves of ultrasound at a specific frequency. When the ultrasoundwaves encounter flowing blood, they are reflected at a shifted frequencythat varies with the velocity of the blood. The transducer probetranslates this shifted frequency back into an electrical signal, whichis processed by the device into an audible and/or visible signalcorresponding to the velocity of the blood.

Usually, such Doppler ultrasound devices utilize a hand-held orstationary enclosure that houses most of the electronics, speaker, and(if applicable) display. A separate probe is connected to the enclosurevia a cable. Existing hand-held Doppler ultrasound devices cannot beused entirely within the sterile field of, e.g., an operating room (OR)because such devices are not designed to be entirely covered with asterile barrier. Thus, a cord must connect a sterile sensor to theunsterile device that is located outside of the sterile field. Ratherthan the surgeon, a second operator is required to operate the device,and often, the second operator must operate competing devices. Further,the cord connecting the sterile sensor to the unsterile device can be atripping hazard in the busy OR environment.

Accordingly, improved handheld ultrasound devices that may be used insterile environments would be desirable. In particular, a handheldultrasound device having a handle and a tip where the entire device issterile would be beneficial. Further, a handheld ultrasound devicehaving a handle and a removable tip where at least the tip is sterilewould be useful. Replaceable sterile tips for a handheld ultrasounddevice that may incorporate a sterile barrier for the reusable componentof the device also would be advantageous.

BRIEF DESCRIPTION

Aspects and advantages of the invention will be set forth in part in thefollowing description, or may be obvious from the description, or may belearned through practice of the invention.

In one aspect of the present subject matter, a handheld ultrasounddevice is provided. The handheld ultrasound device comprises a handleand a tip. The tip comprises a sensor for transmitting and receivingultrasound waves. The handle and the tip are a single, integral, fullyself-contained unit.

In some embodiments, the handheld ultrasound device further comprises apower source that is disposed within the handle. Moreover, the handlemay include a speaker for emitting audible feedback of the receivedultrasound waves. Alternatively or additionally, the handle includes adisplay for displaying visual feedback of the received ultrasound wavesand/or a light array for providing visual feedback of the receivedultrasound waves.

In further embodiments, the handheld ultrasound device is a steriledevice configured for single patient use. In other embodiments, thehandheld ultrasound device is a sterile device configured forre-sterilization after use.

Further, the handle may include one or more controls for operating thehandheld ultrasound device. The one or more controls may include volumebuttons for adjusting the volume of an audible feedback source and apower button for powering the handheld ultrasound device on and off. Instill further embodiments, the handle comprises a port for connectingthe handheld ultrasound device to a source for charging a rechargeablepower source disposed in the handle.

In another aspect of the present subject matter, a handheld ultrasounddevice is provided. The handheld ultrasound device comprises a handleand a tip coupled to the handle. The tip comprises a sensor fortransmitting and receiving ultrasound waves, and the tip is separablefrom the handle. The handle and tip are a fully self-contained unit.

In some embodiments, the tip is operatively coupled to the handle via aconnector. In other embodiments, the tip is operatively coupled to thehandle via a wireless connection. For example, the sensor may wirelesslytransmit the ultrasound waves to a receiver disposed within the handle.In still other embodiments, the tip is tethered to the handle via acable such that the tip is operable when separated from the handle. Adistal end of the tip may define a cavity for storing the cable when thetip is attached to the handle.

In further embodiments, the tip is sterile and incorporates a sterilebarrier for enclosing the handle. In some embodiments, the sterile tipis configured for re-sterilization after use. Alternatively, the steriletip is configured for one-time use.

Moreover, the tip may be replaceable. In some embodiments, a pluralityof different tips are configured for coupling to the handle, each tip ofthe plurality of different tips having a configuration for a particularmedical procedure. In still further embodiments, the tip includes ashaft, and the sensor is positioned on a proximal end of the tip at oneend of the shaft.

Further, a power source may be disposed within the handle. In otherembodiments, a power source is disposed within the tip. Moreover, thehandle may include a speaker for emitting audible feedback of thereceived ultrasound waves. Additionally or alternatively, the handle mayinclude a display for displaying visual feedback of the receivedultrasound waves and/or a light array for providing visual feedback ofthe received ultrasound waves.

In still other embodiments, the handle comprises one or more controlsfor operating the handheld ultrasound device. Additionally oralternatively, the tip comprises one or more controls for operating thehandheld ultrasound device. The one or more controls may include volumebuttons for adjusting the volume of an audible feedback source and apower button for powering the handheld ultrasound device on and off.Further, the handle may comprise a port for connecting the handheldultrasound device to a source for charging a rechargeable power sourcedisposed in the handle. Instead of or in addition to the port in thehandle, the tip may comprise a port for connecting the handheldultrasound device to a source for charging a rechargeable power sourcedisposed in the tip.

In some embodiments, the tip includes a shaft, and the shaft ispermanently deformable. Alternatively, the shaft is temporarilydeformable. In other embodiments, the tip incorporates a curvature alonga length of the tip. In further embodiments, the tip may be flexible,semi-flexible, rigid, or semi-rigid.

In another aspect of the present subject matter, a handheld ultrasoundsterile assembly is provided. The handheld ultrasound sterile assemblycomprises a handheld ultrasound device that includes a handle and a tip.The tip comprises a sensor for transmitting and receiving ultrasoundwaves. The handheld ultrasound sterile assembly further comprises asheath. The sheath fully covers the handheld ultrasound device toprovide a sterile barrier for the device.

In some embodiments, the handle and the tip are a single, integral,fully self-contained unit. In other embodiments, the tip is separablefrom the handle, but together, the handle and tip are a fullyself-contained unit.

Further, the sheath may be shaped complementary to the handheldultrasound device. For example, the sheath may comprise a first portionhaving a diameter and a length complementary to a diameter and a lengthof the tip of the handheld ultrasound device and a second portion havinga width complementary to a width of the handle of the handheldultrasound device.

In yet another aspect of the present subject matter, a tip for ahandheld ultrasound device is provided. The tip comprises a sensor fortransmitting and receiving ultrasound waves, a shaft, and a connectorfor operatively connecting the tip to a handle of the handheldultrasound device. The sensor is positioned on a proximal end of the tipat one end of the shaft.

For instance, the tip may be a replaceable component of the handheldultrasound device. Further, the tip may be sterile and incorporate asterile barrier for enclosing the handle. In some embodiments, thesterile barrier is folded before the tip is attached to the handle.

In further embodiments, the tip is tethered to the handle via a cablesuch that the tip is operable when separated from the handle. A distalend of the tip may define a cavity for storing the cable when the tip isattached to the handle. In some embodiments, the tip comprises thecable, but in other embodiments, the handle comprises the cable.

In still further embodiments, the tip is sterile and is configured forre-sterilization after use. Alternatively, the tip is sterile and isconfigured for one-time use. The tip may be configured for use in aparticular medical procedure.

Moreover, the shaft may be permanently or temporarily deformable.Further, in some embodiments, the tip incorporates a curvature along alength of the tip. The tip may be flexible, semi-flexible, rigid, orsemi-rigid.

These and other features, aspects and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims. The accompanying drawings, which areincorporated in and constitute a part of this specification, illustrateembodiments of the invention and, together with the description, serveto explain the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A full and enabling disclosure of the present invention, including thebest mode thereof, directed to one of ordinary skill in the art, is setforth in the specification, which makes reference to the appendedfigures, in which:

FIG. 1 provides a side, perspective view of a single piece handheldultrasound device, according to an exemplary embodiment of the presentsubject matter.

FIG. 2 provides a side, perspective view of a handheld ultrasound devicecomprising a separable tip and a sterile barrier drawn over a handle ofthe device, according to an exemplary embodiment of the present subjectmatter.

FIG. 3A provides a side, perspective view of a handheld ultrasoundsterile assembly comprising a sheath and the device of FIG. 2 withoutthe sterile barrier, wherein the sheath provides a sterile barrierbetween the device and a patient, according to an exemplary embodimentof the present subject matter in which the sheath has a shapecomplementary to the shape of the device.

FIG. 3B provides a side, perspective view of the assembly of FIG. 3Aaccording to an exemplary embodiment of the present subject matter inwhich the sheath has a same width over its length.

FIG. 4 provides a side, perspective view of the device of FIG. 2, withthe tip separated from the handle and the sterile barrier omitted forclarity.

FIG. 5 provides a side, perspective view of a handheld ultrasound devicecomprising a separable tethered tip, according to an exemplaryembodiment of the present subject matter.

FIG. 6 provides a side, perspective view of a replacement tip for ahandheld ultrasound device, the replacement tip having a sterilebarrier, according to an exemplary embodiment of the present subjectmatter.

FIG. 7 provides a side, perspective view of the replacement tip of FIG.6 comprising a power source and a plurality of controls for controllingthe handheld ultrasound device, according to an exemplary embodiment ofthe present subject matter.

FIG. 8 provides a perspective view of a handheld ultrasound device,according to an exemplary embodiment of the present subject matter,received in an exemplary docking station.

FIG. 9 provides a front view of the handheld ultrasound device of FIG.8.

FIG. 10 provides a back view of the handheld ultrasound device of FIG.8.

FIG. 11 provides a handle end, perspective view of the handheldultrasound device of FIG. 8, with a tip of the device separated from ahandle of the device.

FIG. 12 provides a tip end, perspective view of the handheld ultrasounddevice of FIG. 8, with the tip separated from the handle.

FIG. 13 provides a perspective view of the handle of the handheldultrasound device of FIG. 8.

FIG. 14 provides a side, perspective view of the tip of the handheldultrasound device of FIG. 8 having a sterile barrier, according to anexemplary embodiment of the present subject matter; the tip illustratedin FIG. 14 may be a replacement tip for the device in some exemplaryembodiments of the present subject matter.

FIG. 15 provides a back, perspective view of the tip of FIG. 14 attachedto the handle of FIG. 13 to form the handheld ultrasound device of FIG.8 having the sterile barrier.

FIG. 16 provides a back, perspective view of the assembled device ofFIG. 15 with the sterile barrier drawn over the handle of the device.

FIG. 17 provides a front view of a handheld ultrasound device accordingto an exemplary embodiment of the present subject matter, the devicehaving a shorter tip and more rounded tip sensor than the device ofFIGS. 8-16.

DETAILED DESCRIPTION

Reference will now be made in detail to present embodiments of theinvention, one or more examples of which are illustrated in theaccompanying drawings. The detailed description uses numerical andletter designations to refer to features in the drawings. Like orsimilar designations in the drawings and description have been used torefer to like or similar parts of the invention.

As used herein, the terms “first,” “second,” and “third” may be usedinterchangeably to distinguish one component from another and are notintended to signify location or importance of the individual components.

The terms “upstream” and “downstream” refer to the relative directionwith respect to fluid flow in a fluid pathway. For example, “upstream”refers to the direction from which the fluid flows, and “downstream”refers to the direction to which the fluid flows.

The terms “coupled,” “fixed,” “attached to,” and the like refer to bothdirect coupling, fixing, or attaching, as well as indirect coupling,fixing, or attaching through one or more intermediate components orfeatures, unless otherwise specified herein.

The singular forms “a,” “an,” and “the” include plural references unlessthe context clearly dictates otherwise.

Approximating language, as used herein throughout the specification andclaims, is applied to modify any quantitative representation that couldpermissibly vary without resulting in a change in the basic function towhich it is related. Accordingly, a value modified by a term or terms,such as “about,” “approximately,” and “substantially,” are not to belimited to the precise value specified. In at least some instances, theapproximating language may correspond to the precision of an instrumentfor measuring the value, or the precision of the methods or machines forconstructing or manufacturing the components and/or systems. Forexample, the approximating language may refer to being within a 10percent margin.

Here and throughout the specification and claims, range limitations arecombined and interchanged, such ranges are identified and include allthe sub-ranges contained therein unless context or language indicatesotherwise. For example, all ranges disclosed herein are inclusive of theendpoints, and the endpoints are independently combinable with eachother.

Referring now to the drawings, wherein identical numerals indicate thesame elements throughout the figures, FIG. 1 is a side perspective viewof a handheld ultrasound device 100 according to an exemplary embodimentof the present subject matter. In the depicted embodiment, the device100 has a stylus-like form factor and includes a handle 102 and anintegral tip 104. As shown in FIG. 1 and described herein, the handle102 provides a housing for the various electronics of the device 100,which may include a power source, one or more processors, one or moresignal transmitters and/or receivers, etc., and thus, the handle 102 maybe referred to as a transceiver. The tip 104 incorporates a sensor 106;in an exemplary embodiment, the sensor 106 is a piezoelectric transducerfor sensing the strength and/or pattern of blood flow through a bloodvessel. More particularly, the sensor 106 translates electrical signalsinto ultrasound waves at a specific frequency. When the ultrasound wavesencounter flowing blood, they are reflected at a shifted frequency thatvaries with the velocity of the blood. The sensor 106 translates thisshifted frequency back into an electrical signal that is processed bythe device 100 into an audible, visible, or other signal or feedbackcorresponding to the velocity of the blood. For instance, a suitableprocessor may be housed in the handle 102 of the device 100 thatconverts the electrical signals from the sensor 106 into an audiblesignal delivered to an operator through, e.g., a speaker 108 and/or intoa visual signal delivered to the operator through, e.g., a display 110and/or a light array 112. More specifically, the handle 102 may includea control circuit having one or more processors and associated memorydevice(s) configured to perform a variety of computer-implementedfunctions (e.g., performing the methods, steps, calculations and thelike disclosed herein). As used herein, the term “processor” refers notonly to integrated circuits referred to in the art as being included ina computer, but also refers to a controller, a microcontroller, amicrocomputer, a programmable logic controller (PLC), an applicationspecific integrated circuit, and other programmable circuits.Additionally, the memory device(s) may generally comprise memoryelement(s) including, but not limited to, computer readable medium(e.g., random access memory (RAM)), computer readable non-volatilemedium (e.g., a flash memory), and/or other suitable memory elements.

Such memory device(s) may generally be configured to store suitablecomputer-readable instructions that, when implemented by theprocessor(s), configure the control circuit to perform various functionsincluding, but not limited to, converting the signals from the sensor106 into an audible and/or visual signal and other functions. Moreparticularly, the instructions may configure the control circuit toperform functions such as receiving directly or indirectly signals fromone or more sensors (e.g. voltage sensors, current sensors, and/or othersensors) indicative of various input conditions, and/or various othersuitable computer-implemented functions, which enable the device 100 tocarry out the various functions described herein. An interface caninclude one or more circuits, terminals, pins, contacts, conductors, orother components for sending and receiving control signals. Moreover,the control circuit may include a sensor interface (e.g., one or moreanalog-to-digital converters) to permit signals transmitted from anysensors within the system to be converted into signals that can beunderstood and processed by the processor(s).

The display 110 may provide a waveform and/or numeric value output thatrepresents the blood velocity. The light array 112 may be a series oflight emitting diodes (LEDs) that, in some embodiments, change color or,in other embodiments, are selectively illuminated to represent the bloodvelocity. In still other embodiments, the intensity or on/off status ofthe LED array may also indicate blood velocity. In yet otherembodiments, haptic feedback may be used to indicate blood velocity. Inaddition, one or more visual, audible, tactile, or other indicators,such as LEDs, particular tones, haptic feedback, or the like, may beprovided to indicate a status of the device 100. For example, a firstvisual indicator 114 a indicates whether the device 100 is on or off. Asa particular example, a green LED 114 a is illuminated when the device100 is on, and the LED 114 a indicates the device 100 is off when theLED 114 a is not illuminated. Further, a second visual indicator 114 bindicates whether a power source 115 of the device 100, such as abattery, is sufficient to power the device 100. As a particular example,a red LED 114 b is illuminated when the battery life of a battery forpowering the device 100 that is disposed within the handle 102 is belowa certain percentage, e.g., the LED 114 b is illuminated when thebattery life is 20% or less. As such, when the LED 114 b is notilluminated, the second visual indicator 114 b indicates to an operatorthat the battery life is greater than 20%, which may be sufficient touse the device 100 in a medical procedure. Other or different visual,audible, tactile, or other indicators may be used to indicate to anoperator of the device 100 a status of one or more features of thedevice 100.

In the depicted embodiment, the handle 102 comprises one or morecontrols for operating the device 100. Where the device 100 provides anaudible signal, the handle 102 includes one or more controls foradjusting the volume of the audible feedback source that emits theaudible signal, e.g., the one or more controls are volume buttons 116shown in FIG. 1. For example, when an operator presses a first button116 a, the volume of the audible signal delivered through the speaker108 increases, and when the operator presses a second button 116 b, thevolume decreases. As further illustrated in FIG. 1, the handle 102includes one or more controls, e.g., a power button 118, for poweringthe device 100 on and off. As described above, the device 100 mayinclude an indicator for indicating whether the device 100 is on or off,and in some embodiments, rather than including a separate LED indicatoror the like, the power button 118 may be illuminated when the device 100is on, and the illumination may be extinguished when the device is off.Also, it will be appreciated that the device 100 is a fullyself-contained device and, as such, is powered by a power source 115that is disposed within the handle 102 in the exemplary embodiment ofFIG. 1. That is, the handle 102 and tip 104 together form a fullyself-contained unit. The power source 115 may be, e.g., one or morebatteries that are single use or re-chargeable, and in embodiments inwhich the one or more batteries are re-chargeable, the handle 102defines a port 120 for connecting the device 100 to a source forcharging the one or more re-chargeable batteries disposed in the handle.That is, an optional charging port 120 may be provided for connectingthe rechargeable power source 115 in the handle 102 to a source forre-charging the rechargeable power source 115, such as a power outlet orthe like.

It will be appreciated that the device 100 may have variousconfigurations. For instance, as illustrated in FIG. 1, the device 100may be a single piece, i.e., the handle 102 and tip 104 may be a singleintegral component. In some embodiments of the single piece device 100,the device 100 may be a disposable device configured for single patientor one-time use. That is, the device 100 may be discarded after use in asingle medical procedure. As such, relatively low cost materials, e.g.,the material used to form the handle or housing 102, the power source,the electronics, etc., may be selected for the device 100 and/or somefeatures of the device 100, e.g., the charging port 120, may be omittedto minimize the cost of the single-use device 100. Further, thesingle-use device 100 may be sterile, e.g., the device 100 may be sealedin sterile packaging that is discarded upon opening. In otherembodiments, the single piece device 100 may be reusable and, moreparticularly, may be configured for re-sterilization after use. Forexample, the device 100 may be sufficiently sealed to permit the device100 to be sterilized (e.g., by autoclaving, ethylene oxidesterilization, coating or submerging in a liquid sterilizer, etc.according to a typical sterilization protocol) after each use of thedevice 100. Accordingly, whether packaged in sterile packaging orconfigured for re-sterilization, the entire single piece device 100 maybe sterile for use in an operating room (OR) or other sterile field.

Turning to FIGS. 2-4 and FIGS. 8-16, the device 100 may be a multi-piecerather than a single piece device. Referring particularly to FIGS. 2-5and 9-13, in some embodiments, the handle 102 and tip 104 may beseparate pieces rather than a single integral piece. For example, thetip 104 may be detachable from and attachable to the handle 102. Assuch, the tip 104 (rather than the entire device 100) may be configuredfor single patient or one-time use and may be discarded after use with asingle patient or in a single medical procedure. Thus, as described withrespect to the single piece device 100, where the tip 104 is configuredfor single patient or one-time use, relatively low cost materials may beused to construct the tip 104 to minimize its cost. In otherembodiments, the tip 104 may be reusable and, thus, may be configuredfor re-sterilization (e.g., using a typical sterilization protocol asdescribed above) after use or for non-sterile use in a clinicalenvironment.

In either embodiment, the handle 102 may be separately sterilizable, orthe device 100 may include a sterile barrier 122 that can be drawn overor around the handle 102 such that the unsterile handle 102 may be usedin a sterile environment such as an OR. For example, as shown in FIGS.2, 6, 7, and 14-16, the tip 104 includes a sterile barrier 122, whichmay be gathered in an accordion-type fold as illustrated in FIGS. 6 and7 before deployment over the handle 102. As illustrated in FIGS. 14 and15, other types of folds or gathering of the sterile barrier 122 alsomay be used, e.g., to keep the sterile barrier 122 with the tip 104and/or out of the way before the tip 104 is attached to the handle 102.Further, the sterile barrier 122 may be secured to the tip 104 atdifferent locations. In some embodiments, the sterile barrier 122 issecured to the tip 104 at or near a distal end 134 of the tip 104, asillustrated in FIGS. 2, 6, and 7. In other embodiments, such as shown inFIGS. 14-16, the sterile barrier 122 is secured to the tip 104 between aproximal end 132 and distal end 134 of the tip 104, e.g., just above orbeyond the slits 164 defined in the distal end 134 of the tip 104 asdepicted most clearly in FIG. 16.

To prepare the handle 102 for use in a sterile environment, the tip 104is attached to the handle 102, and the sterile barrier 122 is in afolded position before the tip 104 is attached to the handle 102, asshown in FIGS. 6, 7, and 14. After the tip 104 is attached to the handle102, e.g., as shown in FIG. 15, the sterile barrier 122 is deployed,e.g., by rolling the barrier 122 down over the non-sterile handle 102and closing the barrier 122 at a distal end 124, e.g., as shown in FIGS.2 and 16. For instance, the distal end 124 of the barrier 122 may berolled up to close the end 124; a closure mechanism comprising male andfemale portions that, e.g., are pressed together to interlock the maleand female portions to thereby seal the end 124; and/or a pressuresensitive adhesive, which may be protected from inadvertent or unwantedclosure by a release liner, that attaches the barrier 122 to itself tothereby seal the end 124. Alternatively, the sterile barrier 122 mayextend outside of the sterile field such that the distal end 124 of thebarrier 122 need not be closed, i.e., the sterile barrier 122 may have alength such that its distal end 124 is outside of the sterile field andcan remain open. Further, in suitable embodiments, the sterile barrier122 may be included with the handle 102 rather than the tip 104.

As illustrated in FIGS. 2 and 16, the sterile barrier 122 may be arelatively thin transparent film that allows the controls on the handle102, such as the volume buttons 114 and the power button 116, to beoperated through the barrier 122, as well as allows the audible and/orvisual signals to be communicated through the barrier 122. For instance,an audible signal emitted through the speaker 108 may be heard throughthe sterile barrier 122. In some embodiments, the sterile barrier 122may be made from a thin film polymer such as urethane, polyethylene,polypropylene, or polyvinylchloride.

Referring to FIG. 3A, rather than incorporating a sterile barrier 122 aspart of the device 100, in some embodiments a separate sheath 138 may beprovided that fully covers the handheld device 100 to provide a sterilebarrier and permit the device 100 to be used in a sterile field.Together, the handheld ultrasound device 100 and the sheath 138 form ahandheld ultrasound sterile assembly 140. The sheath 138 may have ashape complementary to the shape of the device 100 and/or may beconfigured to conform to the shape of the device 100. For instance, asshown in FIG. 3, the sheath 138 may include a first portion 138 a havinga diameter d_(sheath1) and length l_(sheath1) complementary to thediameter d_(shaft) and length l_(shaft) of the tip shaft 130 of thedevice 100 and a second portion 138 b having a width (or diameter)w_(sheath2) complementary to the width w_(handle) of the handle 102 ofthe device 100; the second portion 138 b has a length l_(sheath2) thatis longer than the length l_(handle) of the handle 102 to permit sealingof the sheath 138 or to extend outside of the sterile field such thatthe sheath 138 does not have to be sealed. Accordingly, in the depictedembodiment, the sheath 138 has a shape complementary to the shape of thedevice 100 and has a relatively close fit around the device 100.However, in other embodiments, the sheath 138 may have otherconfigurations, e.g., the sheath 138 may have substantially the samewidth (or diameter) w_(sheath) over its entire length l_(sheath) asshown in FIG. 3B. Further, like the sterile barrier 122, the sheath 138may be formed from a relatively thin transparent film, e.g., a thinpolymer film such as urethane, polyethylene, polypropylene, orpolyvinylchloride.

It will be appreciated that, to prepare the device 100 for use in asterile field (such as an OR) using the sheath 138, the tip 104 isattached to the handle 102 to assemble the device 100 and then thedevice 100 is inserted into the sheath 138 or the sheath 138 is drawnover the assembled device 100. Alternatively, as previously described,the device 100 may be a single piece component such that preparing thedevice 100 for use in a sterile field simply comprises inserting thesingle piece device 100 into the sheath 138 or drawing the sheath 138over the single piece device 100. Once the device 100 is within thesheath 138, the sheath may be sealed at a distal end 139 of the sheath,similar to sealing the sterile barrier 122 at its distal end 124.Moreover, it will be understood that, because the sheath 138 is separatefrom the device 100, the sheath 138 may be discarded after use and thedevice 100 re-used in another procedure or with another patient.

As depicted in FIGS. 4 and 11-13, the handle 102 and/or the tip 104 mayinclude a connector 126 for operatively connecting the sensor 106 and/orother electronics in or on the tip 104 to the electronics containedwithin the handle 102. In other embodiments, the sensor 106 maywirelessly connect to the electronics contained within the handle 102,i.e., when the tip 104 is detached from the handle 102, a wirelessoperative connection is established between the sensor 106 and theelectronics within the handle 102 for transmitting and receivingultrasound waves. As such, the sensor 106 can wirelessly transmitultrasound waves, or signals derived from ultrasound waves, to areceiver 107 disposed within the handle 102. The receiver 107 may bepart of a processor, controller, or other such component, which aredescribed in greater detail herein. It will be appreciated that each ofthe handle 102 and tip 104 include appropriate hardware for establishinga wireless connection between the sensor 106 and the electronics. Instill further embodiments, both a wireless and a hard connection betweenthe tip 104 and the handle 102 may be used. For instance, the sensor 106wirelessly connects to the electronics in the handle 102 while the tip104 is used separately from the handle 102, as described herein, and theconnector 126 establishes a hard connection between the tip electronicsand the handle electronics when the tip 104 is attached to the handle102. The hard connection between the tip electronics and the handleelectronics can allow the sensor 106 on the tip 104 to be used with thetip 104 attached to, rather than separated from, the handle 102; canallow a power source within the tip 104, such as the power source 144described herein, to be re-charged, e.g., when the handle 102 isconnected to a power source for re-charging; and/or can allowtransmission of data to and/or from the tip electronics to the handleelectronics.

Further, the handle 102 and tip 104 may be configured to providefeedback that the tip 104 has been properly assembled with the handle102. For example, the tip 104 may be coupled to the handle 102 using afriction fit, with audible feedback such as a click or snap that informsa person assembling the tip 104 with the handle 102 that the tip 104 hasbeen properly attached to the handle 102. As illustrated in FIGS. 8-12and 16, the tip 104 may define one or more slits 164 therein that, e.g.,provide strain relief to the tip 104 as it is attached to the handle102. As further illustrated in FIGS. 11 and 12, the tip 104 also maydefine a protrusion 166 that is received in a groove 168 defined in thehandle 102 to help hold the tip 104 in place with respect to the handle102. It will be appreciated that the protrusion 166 may be received inthe groove 168 with an audible click or snap as described above toinform the user that the tip 104 is attached to the handle 102. In otherembodiments, the tip 104 may be connected to the handle 102 via magneticattachment. In still other embodiments, the tip 104 may be attached tothe handle 102 via mechanical threads, twist lock, sliding dovetailinterlock, elastomeric seal, or any number of other methods of physicalattachment.

Although not illustrated in FIGS. 2-5 and 8-16, it will be appreciatedthat the device 100 illustrated therein may incorporate one or morefeatures illustrated with respect to the device of FIG. 1. For example,the device 100 shown in FIGS. 2-5 and 8-16 may include a display 110, alight array 112, indicators 114 a, 114 b, and/or port 120. Such featuresmay be included or defined on or by the handle 102 of FIGS. 2-5 and 8-16in the same location or in different locations than as depicted inFIG. 1. As further depicted in FIGS. 8-17, features of the device 100,as well as the overall shape or outline of the device 100, may vary inconfiguration between embodiments of the device 100. For example,referring particularly to FIG. 9, the volume and power buttons 116, 118may be round in shape rather than generally rectangular as shown inFIGS. 1-5. As another example, referring to FIG. 11, the speaker 108 maybe disposed at an end surface 170 of the handle 102, rather than on afront surface 162 of the handle 102 as shown in FIGS. 1-5. Additionally,a single indicator 114 may be used to indicate a status of the device100, although in some embodiments the single indicator 114 may bedual-colored, i.e., configured to display two different colors in asingle indicator 114 location. Referring to FIG. 10, a removable cover158 may be provided, e.g., on a back surface 160 of the handle 102opposite the front surface 162 on which the controls 116, 118,indicator(s) 114, display 110, and/or light array 112 are disposed. Theremovable cover 158 can allow access to the power source 115 of thehandle 102 (such as a battery or the like) and/or can allow access toone or more electronic components disposed within the handle 102, suchas a printed circuit board (PCB) or the like used for electricallyand/or operatively connecting the electronics within the handle 102.Further, comparing FIGS. 1, 2, 9, and 17, for example, and as describedin greater detail herein, the tip 104 may have various configurations,including the shape or profile of the sensor 106, the length of the tip104, etc. Moreover, the single piece device 100 or each of the handle102 and tip 104 in a multi-piece device 100 may be waterproof, e.g., tobe more conducive to use in a surgical setting near bodily fluids, tofacilitate sterilization of the device 100 and/or its components 102,104 for re-use following a medical procedure, etc.

Referring now to FIG. 5, in some embodiments, the tip 104 may betethered to the handle 102 by a cable 128 such that the tip 104 may beseparated or detached from the handle 102 while the device 100 is inoperation and be used away from the handle 102. More specifically, someuses of the ultrasound device 100 may require the sensor 106 to beplaced or positioned in a relatively narrow or tight space that will notaccommodate the handle 102 or the combination of the handle 102 and tip104. Accordingly, in embodiments of the device such as shown in FIG. 5,the tip 104 may be detached from the handle such that the sensor 106 canbe used in the narrow or tight location, with the cable 128 providingoperative connectivity between the sensor 106 and the electronics (e.g.,the power source 115, the power switch, the processor, etc.) within thehandle 102 required for the sensor 106 to be operable and to deliver theaudible and/or visual signal(s) to the operator. It will be appreciatedthat, even with the tip 104 detached from the handle 102, the ultrasounddevice 100 remains a handheld device. For instance, an operator may holdthe tip 104 with one hand while holding the handle 102 with the otherhand. Further, the controls on either or each of the tip 104 and handle102, such as the volume and/or power buttons 116, 118 and/or thecontrols 142, may be sized and/or located such that the operator canmanipulate the controls while holding the handle 102 in one hand and thetip 104 in the other hand.

As further illustrated in FIG. 5, the tip 104 may be sized anddimensioned for use in such narrow or tight locations. Moreparticularly, the illustrated tip 104 has an elongated narrow shaft 130,and the sensor 106 is positioned on a proximal end 132 of the tip 104,at one end of the shaft 130. In an exemplary embodiment, the shaft 130may be about four to about five centimeters (about 4-5 cm) in lengthwith a diameter of about one centimeter (about 1 cm) or less. Further, adistal end 134 of the tip 104 may define a cavity 136 in which the cable128 may be contained or stored when the tip 104 is attached to thehandle 102.

Regardless of whether the device 100 is a single piece or multi-piecedevice, the tip 104 may have a different configuration, including adifferent shape and/or size, for use in different medical procedures. Asone example, the tip 104 for use in a gastrointestinal procedure mayhave a different stiffness, shape, and/or size than the tip 104 for usein a cardiology procedure. As such, for embodiments in which the device100 is a single piece, different devices 100 may be provided fordifferent procedures, with the devices for the different proceduresdiffering at least as to the configuration of their tips 104. Forembodiments in which the device 100 utilizes tips 104 that are formedseparately from the handle 102 and are attachable to the handle 102, onetip 104 may be attached to the handle 102 for one procedure, and adifferent tip 104 may be attached to the handle 102 for a differentprocedure. That is, the same handle 102 may be used for differentprocedures, with a tip 104 specific to the respective procedure attachedto the handle 102. Further, the tip 104 may have differentconfigurations for use in different portions of a single procedure;e.g., a first tip 104 may be used in a first area of a patient's bodywhile a second tip 104 may be used in a second area of the patient'sbody.

As examples of aspects of the tip 104 that may vary between embodiments,in some embodiments, the tip 104 may be flexible, semi-flexible, rigid,or semi-rigid. In other embodiments, the tip 104 may incorporate acurvature, bend, or angle along its length, e.g., as illustrated in FIG.1 where the tip 104 is curved near the sensor 106, and in exemplaryembodiments, the radius of curvature is at most 90° (i.e., less than orequal to 90°). For instance, the tip 104 may be configured for use inprocedures in which the velocity of blood is measured in blood vesselsbehind the heart (as with respect to the direction from which the heartis approached with the device 100), and the tip 104 includes a curve,bend, or angle sufficient to allow the sensor 106 to be positionedbehind the heart, i.e., the tip 104 is angled, bent, or curved to allowaccess to the blood vessels by the sensor 106. In yet other embodiments,the tip 104 may be permanently deformable, e.g., an operator may bendthe tip 104 and the tip 104 remains in the bent configuration, ortemporarily deformable, e.g., an operator may bend the tip 104 and thetip 104 remains in the bent configuration for a period of time beforereturning to a default configuration, such that the operator cancustomize the shape of the tip 104. For example, the tip shaft 130 maybe formed from a material that permits deformation of the shaft 130 to adesired shape and retention of the desired shape. Of course, it will beappreciated that the tips 104 may incorporate other differences as well,e.g., a diameter of the shaft 130 and/or a length of the shaft 130 mayvary between tips 104.

As described herein, the handheld ultrasound device 100 may be amulti-piece device comprising a handle 102 and a separate tip 104, suchthat the tip 104 may be a replaceable component of the device 100 andprovided separately from the device 100 as shown in FIG. 6. As anexample, the tip 104 may be configured for single use, and a new steriletip 104 may be attached to the handle 102 for each use of the device100, with each tip 104 being discarded after use. However, in otherembodiments, the replaceable tip 104 may be configured for multiple usesand have features allowing the tip 104 to be sterilized after use. Aspreviously described, whether configured for single patient use,one-time use, or to be re-sterilized, at least some embodiments of thereplaceable tips 104 may incorporate a sterile barrier 122, which may bedeployed over or around the handle 102 to allow a non-sterile handle 102to be used in a sterile environment such as an OR. Additionally, eachreplaceable tip 104 includes at least one sensor 106 and features foroperatively coupling the at least one sensor 106 to the controls housedin the handle 102, e.g., via a connector 126. In some embodiments, thereplaceable tip 104 has a shaft 130, which separates the at least onesensor 106 from the handle 102, i.e., the at least one sensor 106 isdisposed on a proximal end 132 of the shaft 130 and the opposite distalend 134 of the shaft 130 is configured for attaching the tip 104 to thehandle 102. In other embodiments, the tip 104 may be configured foroperative coupling or tethering to the handle 102, e.g., wirelessly orvia a cable 128, such that the at least one sensor 106 may be operatedaway from the handle 102. A cable 128 may be provided with thereplaceable tip 104, such that a new cable 128 is provided with each tip104, or the handle 102 may comprise the cable 128, such that the cable128 need not be replaced each time the tip 104 is replaced. In eitherembodiment, a distal end 134 of a shaft 130 of the tip 104 may define acavity 136 for housing the cable 128 when the tip 104 is attached to thehandle 102.

Moreover, as shown in FIG. 7, the tip 104 may include one or morecontrols 142 for operating or controlling the device 100 when the tip104 is operated away from the handle 102. For example, the tip 104 mayinclude a power source 144, such as one or more batteries, and the oneor more controls 142 includes a control 142 a for activating ordeactivating the power source. Where the power source 144 is arechargeable battery or the like, the tip 104 also may include a port146 for connecting the rechargeable power source 144 to a chargingsource.; i.e., an optional charging port 146 may be provided forconnecting the rechargeable power source 144 in the tip 104 to acharging source such as a power outlet. As another example, the one ormore controls 142 located on the tip 104 may include controls foradjusting or controlling feedback from the sensor 106, e.g., volumebuttons 142 b, 142 c for adjusting the volume of an audible feedbacksource such as the speaker 108. In appropriate embodiments, the tip 104also may incorporate one or more sources of feedback, e.g., the tip 104may include an LED light array similar to the light array 112 shown inFIG. 1 for providing visual feedback of the ultrasound waves received bythe sensor 106. It will be appreciated that the power source, controls142, and/or feedback sources of the tip 104 may be in addition to or asan alternative to the power source, controls 116, 118, etc., andfeedback sources of the handle 102.

Further, two or more different configurations of replaceable tips 104may be provided such that one configuration of tip 104 may be used forone procedure and a different configuration of tip 104 used for adifferent procedure. Thus, the device 100 may be configured for use indifferent procedures by merely attaching or operatively coupling adifferent tip 104 to the handle 102. That is, different tips 104 may beattached to the handle 102, e.g., at a connector 126 or using a cable128, or may be operatively connected to the handle 102 through awireless connection.

Additionally, although described primarily with respect to FIGS. 6 and7, it will be appreciated that replaceable tips 104 for the device 100may have any appropriate configuration. For example, the tips 104, whichmay be available for purchase separately from the device 100 and/orhandle 102, can have any of the tip configurations illustrated anddescribed herein, as well as any other configurations within the scopeof the present subject matter. As a particular example, the tip 104illustrated in FIGS. 8-12 may be provided as a separate component, thetip 104 illustrated in FIG. 17 may be provided as a separate component,and/or the tip 104 illustrated in FIGS. 14-16, having a sterile barrier122, may be provided as a separate component. Therefore, tips 104 havingany number or variety of configurations may be produced and procuredseparately from the device 100 and/or handle 102.

Referring to FIG. 8, in some embodiments, the handheld ultrasound device100 may be received in a docking station 148, e.g., to re-charge a powersource 115, 144 within the handle 102 or tip 104, to transfer data orother information from the device 100 to a processing device such as acomputer or the like, etc. For instance, rather than including chargingports 120 and/or 146, the device 100 may include one or more openings150 (FIG. 11) for receipt of one or more prongs (not shown) of thedocking station 148, through which an electrical connection isestablished to re-charge the one or more power sources within the device100. The docking station 148 includes one or more features forsupporting the device 100. For example, the docking station 148 definesa depression 152 in which the device 100 is received, and the dockingstation 148 includes a support segment 154 that contacts at least aportion of the device 100, e.g., to keep the device 100 in an uprightposition and/or to maintain the charging prong(s) of the docking station148 within the opening(s) 150 of the device 100. Further, the dockingstation 148 also may include one or more features for indicating thestatus of the device 100 to a user of the device 100. In the depictedembodiment, the docking station 148 includes an indicator 156, which maybe an LED light or the like for indicating to the user whether thedevice 100 is charging. Other indicators 156 may be provided, e.g., toindicate to the user whether the device 100 is transferring data to aseparate device or any other state or status of the device 100.

Accordingly, as described herein, the handheld ultrasound device 100 isa fully self-contained Doppler ultrasound device. That is, the device100 incorporates all features needed to transmit and receive ultrasoundwaves, as well as convert such waves into one or more signals that maybe understood by an operator of the device 100 to indicate an assessedvalue, e.g., the strength and/or pattern of blood flow through a bloodvessel. Thus, the handheld device 100 described herein may be operatedentirely in a sterile field, e.g., by a doctor or clinician in aclinical setting or a surgeon in a surgical setting, which can eliminatea cord between a sensor tip in the sterile field or environment and areceiver outside the sterile field (which could be a trip hazard in asurgical setting), as well as eliminate a second operator to manage aportion of the device's operation (e.g., outside the sterile field).Moreover, the various embodiments of the device 100 illustrated anddescribed herein have a stylus-like form factor, which reduces theoverall footprint of the device. The reduced footprint andself-contained nature of the device 100 make handheld Doppler ultrasoundmore conducive to clinical and surgical use. In addition, the reducedsize of the device 100 allows the device 100 to be protected by asterile barrier 122 as described herein, or may reduce the cost offorming the device 100 (or its components, such as tip 104) as a singlepatient or one-time use sterile device.

Further, the device 100 may be a single piece device configured forsingle patient use, one-time use, or for multiple uses. For example, thesingle piece device 100 may be a sterile device (e.g., may be providedin sterile packaging) that is disposed of after a single use or that isconfigured for re-sterilization after each use. In other embodiments,the device 100 may be a multi-piece device that comprises a handle 102and a separate tip 104; the tip 104 includes at least one sensor 106 fortransmitting and receiving ultrasound waves. As such, the tip 104 may bea replaceable component, which allows (1) a new sterile tip 104 to beused for each procedure while the handle 102 may be re-used for multipleprocedures or (2) a different configuration of tip 104 to be used fordifferent procedures while the same handle 102 is used for the differentprocedures. In such embodiments, the tip 104 may incorporate a sterilebarrier 122 such that the handle 102 need not be a sterile component ofthe device 100; rather, the sterile barrier 122 ensures the sterility ofthe handle 102 such that the device 100, including a sterile tip 104 anda handle 102 enclosed within a sterile barrier 122, may be used in asterile environment such as an OR. Other advantages of the subjectmatter described herein also may be realized by those of ordinary skillin the art.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the invention, including making and using any devices orsystems and performing any incorporated methods. The patentable scope ofthe invention is defined by the claims and may include other examplesthat occur to those skilled in the art. Such other examples are intendedto be within the scope of the claims if they include structural elementsthat do not differ from the literal language of the claims or if theyinclude equivalent structural elements with insubstantial differencesfrom the literal language of the claims.

What is claimed is:
 1. A handheld ultrasound device, comprising: ahandle; and a tip, the tip comprising a sensor for transmitting andreceiving ultrasound waves, wherein the handle and the tip are a single,integral, fully self-contained unit.
 2. The handheld ultrasound deviceof claim 1, wherein a power source is disposed within the handle.
 3. Thehandheld ultrasound device of claim 1, wherein the handle includes aspeaker for emitting audible feedback of the received ultrasound waves.4. The handheld ultrasound device of claim 1, wherein the handleincludes a display for displaying visual feedback of the receivedultrasound waves.
 5. The handheld ultrasound device of claim 1, whereinthe handle includes a light array for providing visual feedback of thereceived ultrasound waves.
 6. The handheld ultrasound device of claim 1,wherein the handheld ultrasound device is a sterile device configuredfor single patient use.
 7. The handheld ultrasound device of claim 1,wherein the handheld ultrasound device is a sterile device configuredfor re-sterilization after use.
 8. The handheld ultrasound device ofclaim 1, wherein the handle comprises one or more controls for operatingthe handheld ultrasound device.
 9. The handheld ultrasound device ofclaim 8, wherein the one or more controls include volume buttons foradjusting the volume of an audible feedback source and a power buttonfor powering the handheld ultrasound device on and off.
 10. The handheldultrasound device of claim 1, wherein the handle comprises a port forconnecting the handheld ultrasound device to a source for charging arechargeable power source disposed in the handle.
 11. The handheldultrasound device of claim 1, wherein the tip incorporates a curvaturealong a length of the tip.
 12. The handheld ultrasound device of claim1, wherein the handle comprises a port for connecting the handheldultrasound device to a source for charging a rechargeable power sourcedisposed in the handle.
 13. The handheld ultrasound device of claim 1,wherein the tip is flexible.
 14. The handheld ultrasound device of claim1, wherein the tip is rigid.
 15. The handheld ultrasound device of claim1, wherein a sheath fully covers the handheld ultrasound device toprovide a sterile barrier for the handheld ultrasound device, andwherein the sheath is separate from the handheld ultrasound device. 16.A handheld ultrasound sterile assembly, comprising: a handheldultrasound device including a handle and a tip, the tip comprising asensor for transmitting and receiving ultrasound waves, the handle andtip formed as a single, integral, fully self-contained unit; and asheath, wherein the sheath fully covers the handheld ultrasound deviceto provide a sterile barrier for the device.
 17. The handheld ultrasoundsterile assembly of claim 16, wherein the sheath is shaped complementaryto the handheld ultrasound device.
 18. The handheld ultrasound sterileassembly of claim 17, wherein the sheath comprises a first portionhaving a diameter and a length complementary to a diameter and a lengthof the tip of the handheld ultrasound device, and wherein the sheathcomprises a second portion having a width complementary to a width ofthe handle of the handheld ultrasound device.
 19. A handheld ultrasounddevice, comprising: a handle; and a tip, the tip comprising a sensor fortransmitting and receiving ultrasound waves, wherein the sensor ispositioned on a proximal end of the tip, and wherein the handle and thetip are a single, integral, fully self-contained unit.
 20. The handheldultrasound device of claim 19, wherein the tip has a shape and a sizefor a specific medical procedure.